NCT06723522招募中不适用
The Efficacy and Brain Mechanism of High Definition Transcranial Direct Current Stimulation of Right Inferior Frontal Gyrus to Improve Social Impairments in Children with Autism Spectrum Disorder: a Randomized, Double-blind, Controlled Study
Central South University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Social function as measured by the Social Responsiveness Scale-2nd Edition(SRS-2)
研究概览
简要总结
The goal of this clinical trial is to learn if high definition transcranial direct current stimulation (HD-tDCS) of right inferior frontal gyrus works to improve social impairments in children with autism spectrum disorder (ASD). It will also learn about the underlying brain mechanism. The main questions it aims to answer are:
- Does HD-tDCS of right inferior frontal gyrus improve social impairments in children with ASD?
- What are the underlying brain mechanisms by which the HD-tDCS of right inferior frontal gyrus improves social impairments in children with ASD? Researchers will compare participants received active HD-tDCS to controls received sham HD-tDCS (performed to mimic the sensation induced by real HD-tDCS before and after the stimulation) to see if HD-tDCS of right inferior frontal gyrus improves social impairments in children with ASD.
Participants will:
- Receive a dose of 2 mA HD-tDCS of right inferior frontal gyrus lasting for 10 days.
- Receive social functioning assessment, functional near-infrared spectroscopy and electroencephalography measurement before and after stimulation
- Visit the clinic once every 2 weeks for checkups and tests, a total of 2 times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •had to be 3-18 years old; be diagnosed with ASD (according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and Autism Diagnostic Interview - Revised (ADI-R).
排除标准
- •with other comorbid neuropsychiatric conditions (i.e., schizophrenia spectrum disorders and mood disorders) or neurological disorders (i.e., head trauma and epilepsy).
结局指标
主要结局
Social function as measured by the Social Responsiveness Scale-2nd Edition(SRS-2)
时间窗: Social functioning was assessed before stimulus onset, immediately after stimulus completion, at week 2 after completion, and at week 4 after completion.
SRS-2 is a highly reliable and sensitive scale to measure social function in RCTs involving individuals with autism.
次要结局
- The resting-state functional connectivity between the right inferior frontal gyrus and other brain regions involving social function as measured by functional near-infrared spectroscopy(before stimulus onset, immediately after stimulus completion, at week 2 after completion, and at week 4 after completion.)
研究者
Xuerong Luo
Doctor
Central South University
研究点 (1)
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